Radial Versus Femoral Secondary Access During TAVI (R-TAVI)

Carilion Clinic

Status: Terminated

Conditions: Vascular Access Complication; Aortic Valve Disease; Aortic Stenosis

Treatments: Procedure: Secondary Femoral Artery Access; Procedure: Secondary Radial Artery Access

Study type: Interventional

Funder types: Other

Identifiers

NCT03879824

2611

Details and patient eligibility

About

The R-TAVI study is a randomized pilot study examining the use of the right radial artery versus the femoral artery for secondary vascular access during transcatheter aortic valve implantation (TAVI).

Full description

The R-TAVI study is a prospective, single institution, pilot study in which eligible TAVI patients will be randomized pre-procedurally to receive either secondary radial artery (RA) access or femoral artery (FA) access during TAVI. Our study will take place over a projected 18 month enrollment period.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient meets eligibility for TAVR as decided upon by pre-TAVR testing (Echo, cardiac catheterization, CTA TAVR, 2 CT surgical consults, heart team discussion). 2) Undergoing TAVR procedure and follow-up at Carilion Clinic Cardiology Roanoke Memorial Hospital (CRMH) 3) Patient's secondary vascular access can be performed femorally OR radially, as determined by TAVR operator after review of pre-TAVR CT scan imaging.

2. Interventional Cardiologist performing the TAVR agrees to consider patient for enrollment.

3. Patient provides consent 6) Age ≥ 18 years old 7) No evidence of precluding arterial disease of both femoral arteries 8) No evidence of precluding arterial disease of right radial and subclavian arteries 9) Must have palpable pulses in both radial arteries

Exclusion criteria

1. Review of pre-TAVR CT scan imaging deems patient unsuitable for radial OR femoral secondary access based on presence of excessive calcification, stenosis, or tortuosity of the femoral, subclavian, or innominate arteries.
2. Valve implantation (primary access) planned via alternative vascular access (trans-caval, axillary, carotid, direct aortic, trans-apical)-as determined by implanting Interventional Cardiologist/TAVR operator.
3. Prior coronary artery bypass graft surgery in which a radial artery graft was harvested and used as a conduit.
4. Patients on hemodialysis OR with arteriovenous fistulas.
5. Interventional Cardiologist performing the TAVR declines patient consideration in the study.
6. Patient declines consent.
7. Urgent or emergent TAVI cases
8. Patient is already participating in another clinical research study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Radial Artery Secondary Access During TAVI

Experimental group

Description:

Patients randomized to this arm will undergo primary access for valve placement through the femoral artery and will have secondary vascular access for placement of the pigtail catheter through the radial artery (right radial artery only) during their transcatheter aortic valve implantation (TAVI) The active intervention in this arm of the study is secondary radial artery access during TAVI

Treatment:

Procedure: Secondary Radial Artery Access

Femoral Artery Secondary Access During TAVI

Active Comparator group

Description:

Patients randomized to this arm will undergo primary access for valve placement through the femoral artery and will have secondary vascular access for placement of the pigtail catheter through the contralateral femoral artery artery during their transcatheter aortic valve implantation (TAVI) The active intervention in this arm of the study is secondary femoral artery access during TAVI

Treatment:

Procedure: Secondary Femoral Artery Access